Z-0288-2024 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
October 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1687 units

Product Description

EVIS EXERA III Gastrointestinal Videoscope

Reason for Recall

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

Distribution Pattern

Nationwide Distribution.

Code Information

Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.